At a glance
ClinicalIndex Comparison RecordN/ACompleted· 24 enrolled
Drug / intervention
Elzsa film-coated tablet +1 moredrug
Likely dose
Elzsa film-coated tablet 240 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Bioequivalence Study of 2 mg Cyproterone Acetate and 0.035 mg Ethinyl Estradiol in Indonesian Healthy Females
In Brief
A clinical study evaluating Elzsa film-coated tablet and Diane-35 Sugar-coated tablet for Drug Use. Completed, enrolled 24 participants across 1 site.
Detailed Summary
The study was conducted to investigate whether 2 mg cyproterone acetate (CPA) and 0.035 mg ethinyl estradiol (EE) film-coated tablet (Elzsa®) manufactured by PT. Sydna Farma was bioequivalent to its reference product, Diane®-35 sugar-coated tablet manufactured by Bayer Weimar GmbH, Germany, imported by PT. Bayer Indonesia, Depok, Indonesia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDrug Use
CountriesIndonesia
CollaboratorsPT Pharma Metric Labs
Timeline
N/ACompletedFinished
20192020202120222023202420252026
Enrollment StartMar 2019
Primary CompletionJul 2019
Study CompletionSep 2019
First PostedJul 2021
TodayJul 2026
First PostedJul 16, 2021
Enrollment StartMar 12, 2019
Primary CompletionJul 4, 2019
Study CompletionSep 26, 2019
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 5.0 years ago
Interventions
Elzsa film-coated tabletdrug
Administered with 240 mL of water
Diane-35 Sugar-coated tabletdrug
Administered with 240 mL of water